Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

UP­DAT­ED: Mod­er­na says Covid-19 boost­ers stand a fight­ing chance against new vari­ants

A day be­fore its sec­ond an­nu­al Vac­cines Day, Mod­er­na has post­ed an up­date on its crown jew­el, in­clud­ing a 6-month look at the Covid-19 shot and new pre­clin­i­cal da­ta that sug­gest its boost­er can­di­dates stand a fight­ing chance against new vari­ants.

Mod­er­na’s vari­ant-spe­cif­ic boost­er mR­NA-1273.351, which was de­signed to tar­get the B.1.351 mu­ta­tion first iden­ti­fied in South Africa, “closed the neu­tral­iz­ing titer gap for vari­ants of con­cern” in mice, the com­pa­ny said on Tues­day af­ter­noon. When giv­en at the 6-month mark, the boost­er elicit­ed neu­tral­iz­ing titers against the vari­ant that were com­pa­ra­ble to those pro­duced against the orig­i­nal virus.

mR­NA-1273.211, a com­bi­na­tion of mR­NA-1273.351 and Mod­er­na’s al­ready au­tho­rized vac­cine, al­so in­creased neu­tral­iz­ing titers against vari­ants ac­cord­ing to the pre­clin­i­cal re­sults, which have been sub­mit­ted to bioRx­iv but haven’t been pub­lished.

“The new pre­clin­i­cal da­ta on our vari­ant-spe­cif­ic vac­cine can­di­dates give us con­fi­dence that we can proac­tive­ly ad­dress emerg­ing vari­ants,” CEO Stéphane Ban­cel said in a state­ment. “Mod­er­na will make as many up­dates to our COVID-19 vac­cine as nec­es­sary un­til the pan­dem­ic is un­der con­trol.”

Ban­cel told End­points News that he ex­pects the virus to mu­tate very quick­ly in the next cou­ple years, be­cause a lot of peo­ple haven’t yet been vac­ci­nat­ed or in­fect­ed. Then in 2023 or 2024, he pre­dicts the speed at which the vac­cine mu­tates could slow down.

“We think that in the next two years, there might be a need for sev­er­al boosts, es­pe­cial­ly for peo­ple at high risk,” he said. “We think over time, maybe a boost per year might be enough, es­pe­cial­ly if com­bined with your flu boosts.”

As for the orig­i­nal vac­cine, an up­dat­ed re­view of 900-plus Covid-19 cas­es from the Phase III COVE study con­firms the jab is more than 90% ef­fec­tive against all cas­es, and over 95% ef­fec­tive against se­vere cas­es. A study with 33 Phase I par­tic­i­pants showed that an­ti­bod­ies per­sist­ed 6 months af­ter the sec­ond dose, ac­cord­ing to re­sults pub­lished in the New Eng­land Jour­nal of Med­i­cine. Mod­er­na be­lieves ef­fi­ca­cy kicks in two weeks af­ter the sec­ond dose.

As part of its own up­dat­ed re­view, Pfiz­er said its BioN­Tech-part­nered jab demon­strat­ed “strong pro­tec­tion” 6 months af­ter the sec­ond dose, with an over­all ef­fi­ca­cy rate of 91.3%.

Mod­er­na’s Phase II/III Teen­COVE study is ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US, ac­cord­ing to the com­pa­ny. That tri­al will as­sess a 100 µg dose of the vac­cine. Mean­while, the Phase II/III Kid­COVE study is still re­cruit­ing chil­dren be­tween 6 months and 11 years old. Mod­er­na hopes to en­roll 6,750 healthy par­tic­i­pants in the US and Cana­da for the two-part dose es­ca­la­tion study. In Part 1, chil­dren be­tween the ages of 2 and 12 will re­ceive ei­ther 50 μg or 100 μg of the vac­cine, and those who are younger will be giv­en one of three dose lev­els — 25 μg, 50 μg or 100 μg. An in­ter­im analy­sis will de­ter­mine which dose is used in Part 2.

The news comes as the US paus­es the roll­out of J&J’s vac­cine to re­view da­ta around six re­port­ed cas­es of a rare and se­vere type of blood clot. The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is meet­ing to­mor­row to fur­ther re­view these cas­es and as­sess their po­ten­tial sig­nif­i­cance.

The EMA re­port­ed 3 cas­es of cere­bral ve­nous si­nus throm­bo­sis among the 4.5 mil­lion peo­ple vac­ci­nat­ed with J&J’s shot world­wide. By com­par­i­son, 169 cas­es of CVST and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed among 34 mil­lion peo­ple who re­ceived the As­traZeneca vac­cine in the EEA and UK. Thir­ty-five CVST cas­es were found world­wide among those who have re­ceived the Pfiz­er shot, and 5 for Mod­er­na.

“A com­pre­hen­sive as­sess­ment of the to­tal­i­ty of the avail­able safe­ty da­ta for mR­NA-1273 af­ter over 64.5 mil­lion dos­es ad­min­is­tered glob­al­ly does not sug­gest an as­so­ci­a­tion with CVST or throm­bot­ic events, based on analy­ses per­formed us­ing da­ta through March 22, 2021,” Mod­er­na said in a state­ment.

The CDC has is­sued a state­ment that its Vac­cine Ad­verse Event Re­port­ing Sys­tem “has re­ceived no re­ports of CVST with throm­bo­cy­tope­nia among per­sons who re­ceived ei­ther of the two mR­NA-based COVID-19 vac­cines.”

As of April 12, Mod­er­na had shipped out 132 mil­lion dos­es world­wide, in­clud­ing about 117 mil­lion to the US. Rough­ly 88 mil­lion dos­es were de­liv­ered to the US in Q1, in ad­di­tion to about 14 mil­lion else­where. Plans are in place to ramp up the com­pa­ny’s ex-US sup­ply chain.

Mod­er­na says it’s on track to de­liv­er 100 mil­lion dos­es to the US by the end of May, and an­oth­er 100 mil­lion by the end of Ju­ly.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.

The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.